(55 days)
Not Found
No
The description focuses on the electro-optical nature of the sensor and its function based on light absorption. There is no mention of AI, ML, or any algorithms that would suggest their use. The performance studies described are standard clinical hypoxia studies and electrical/EMC testing, not studies related to AI/ML model performance.
No
The device is a sensor used for monitoring physiological parameters (oxygen saturation and pulse rate) and does not directly provide therapy.
Yes
The device is indicated for "continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring," which are measurements used to assess a patient's physiological state, thus aiding in diagnosis.
No
The device description explicitly details hardware components such as LEDs, a photodiode, housing (adhesive film, clip, wrap), a sensor cable, and a connector. It also mentions electrical safety and EMC testing, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring." This describes a device that monitors physiological parameters directly from the patient's body, not a device that analyzes samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details an "electro-optical sensor" that functions "without skin penetration, electrical contact, or heat transfer." It uses light to measure oxygen saturation and pulse rate. This is a non-invasive monitoring technique.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly measures physiological signals from the patient.
N/A
Intended Use / Indications for Use
The Mediaid SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
2 or s which was conducted during clinical hypoxia studies conducted in an independent research lab. Mediaid SpO2 sensors were compared to arterial blood mucpendent research fab. Theatars Specieseter and found to be equivalent to predicate Samples analyzed on a facorater J ou vi formed to verify pulse rate accuracy.
Biocompatibility, electrical safety, and EMC testing was also performed to demonstrate conformance with established industry standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K994372, K911191, K863784, K030930, K962156, K983684, K991823, K991823
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Appendix C Page 1 of 1
SEP 1 4 2004
510(k) Summary
Submitter Information:
Mediaid, Inc. 4025 Spencer St., Suite 103 Torrance, CA 90503
Contact:
Mahesh Patel, COO Telephone: 310-793-8844 Fax: 310-793-8740
Date Prepared: July 15, 2004
Product Name:
Common Name: SpO2 Sensor (accessory to pulse oximeter)
Predicate Device:
Mediaid (formerly Palco) currently markets its own pulse oximetry system under K994372 and K911191. Mediaid wishes to extend its product line to include its own brand of pulse oximeter sensors that are compatibile with Nellcor, BCI, and Datex pulse oximeters. Nellcor, BCI, and Datex pulse oximeter sensors are marketed under K863784, K030930, K962156, and K983684, K991823, and K991823.
Description:
Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
Intended Use:
Mediaid SpO2 Sensors are indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
1
Comparison to Predicate Device:
Mediaid SpO2 Sensors use the same theory and principle of operation as the predicate Mevice. Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by product testing and accuracy claims.
Performance Data & Conclusions:
2 or s which was conducted during clinical hypoxia studies conducted in an independent research lab. Mediaid SpO2 sensors were compared to arterial blood mucpendent research fab. Theatars Specieseter and found to be equivalent to predicate Samples analyzed on a facorater J ou vi formed to verify pulse rate accuracy.
Biocompatibility, electrical safety, and EMC testing was also performed to demonstrate conformance with established industry standards.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 2004
Mediaid, Incorporated C/O Ms. Krista Oakes Principal Amica Solutions 2300 McDermott Road # 200-207 Plano, Texas 75025
Re: K041964
Trade/Device Name: Mediaid SpO2 Sensor Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 10, 2004 Received: September 10, 2004
Dear Ms. Oakes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Oakes
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled on that your device complies with other requirements mean that FDA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally receital statutes and regaratests, including, but not limited to: registration You must comply with an the Act 3 roquite.com/s/21/centers/2017); good manufacturing practice and if the (21 CFR Part 607), labolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mailoring your device of your device to a premarket nothleation. The I Dr mining or sassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your do roo su caracter also, please note the regulation please contact the Online of Comphanes an (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sman Manatactacions , 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Clive
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix B Page 1 of 1
Statement of Indications For Use
K641964 510(k) # Device Name: Mediaid SpO2 Sensor
Indications for Use:
The Mediaid SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _X
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Auu Sulion
(Division Sign-Off) (Division Sign-Ont
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K041484